Kornimate/medical-research-clean huggingface dataset:
darolutamide in addition to adt versus adt in metastatic hormone-sensitive prostate cancer

Conditions: Prostatic Neoplasms

Summary: the purpose of the study is to assess the efficacy and safety of darolutamide in combination with standard androgen deprivation therapy (adt) in patients with metastatic hormone sensitive prostate cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of prostate * metastatic disease * started adt (lhrh agonist/antagonist or orchiectomy) with or without first generation anti-androgen, but not earlier than 12 weeks before randomization * eastern cooperative oncology group (ecog) performance status (ps) of 0, 1 or 2 * adequate bone marrow, liver and renal function exclusion criteria: * prior treatment with: lhrh agonist/antagonists except neoadjuvant and /or adjuvant therapy; second-generation androgen receptor (ar) inhibitors such as enzalutamide, darolutamide, apalutamide or other investigational ar inhibitors; cytochrome p17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as anti-cancer treatment for prostate cancer; chemotherapy including docetaxel or immunotherapy for prostate cancer; use of systemic corticosteroid with dose greater than the equivalent 10 mg of prednisone/day within 28 days prior to randomization; radiopharmaceuticals; any other anti-cancer treatment for prostate cancer, excluding local therapies and adt. * treatment with radiotherapy within 2 weeks before randomization * contraindication to iodinated ct and gadolinium chelate mri intravenous contrast agent(s) * had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (new york heart association class iii or iv) * uncontrolled hypertension as indicated by a resting systolic bp ≥ 160 mmhg or diastolic bp ≥ 100 mmhg despite medical management * a gastrointestinal (gi) disorder or procedure which is expected to interfere significantly with absorption of study drug * any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to randomization * inability to swallow oral medications

Keywords: metastatic hormone-sensitive prostate cancer
the effect of progressive relaxation exercise on fatigue and comfort level after major orthopedic surgery

Conditions: Orthopedic Surgery

Summary: this study was planned to determine the effect of progressive relaxation exercise to be applied after major orthopedic surgery on post-operative fatigue and comfort level.

the symptom of fatigue causes tension, anxiety, fear, and insomnia in the person. fatigue also negatively affects the comfort level of the patient along with the symptoms experienced in individuals.suggestions and evaluations of the professional healthcare team, especially nurses, are of great importance in the effective fight against fatigue of patients.in this study, it is carried out to determine the effect of progressive relaxation exercise applied after major orthopedic surgery on fatigue and comfort level. hypothesis h1: progressive relaxation exercise to be applied after major orthopedic surgery reduces the post-operative fatigue level of patients. h2: progressive relaxation exercise to be applied after major orthopedic surgery positively affects the comfort level of the patients.

Eligibility criteria:
inclusion criteria: * the patients included in the study have undergone major orthopedic surgery (total knee or hip replacement, atroscopic surgery, vertebral surgery, shoulder surgery, amputation, etc.), patients aged 18 and over absence of speech and hearing problems speak and understand turkish exclusion criteria: * being diagnosed with a psychiatric disorder, a complication developed in the patients before, during and three days after the operation,
patient reported outcomes/metrics program trial

Conditions: Metastatic Cancer; Palliative

Summary: this is an observational study to investigate if it is feasible to recruit 100 patients receiving radiotherapy (rt) to metastatic disease to wear hexoskin and if hexoskin will facilitate the monitoring, detection and early treatment of rt-related side effects.

radiotherapy is an important adjunct in the interdisciplinary care of the palliative patient population, providing the potential for improved quality of life and symptom control, often translating into improved well-being, function and mobility. changes in pain and qol are frequently measured subjectively using patient-reported questionnaires. objective measures such as respiratory rate, pulse rate, activity level and sleep duration and quality, may complement the currently available tools. such tools may lead to better evaluation of the effects of palliative rt with real-time detection of potential complications and toxicity and the acute need for analgesic adjustments that can result from successful palliative rt.

Eligibility criteria:
inclusion criteria: * planned to receive palliative radiotherapy for pain * known cancer diagnosis * able to wear hexoskin medical shirt * ability to use and populate the mobile app (zamplo) with or without assistance * ecog: 0-3 * willing to provide a list of analgesic (pain relief) medication * willing to complete questionnaires * life expectancy of at least 3 months exclusion criteria: * receiving whole brain radiotherapy * major cognitive or psychiatric impairments * pregnant women * allergies to: polyester, synthetic fibers * patients with pacemakers or implantable cardioverter-defibrillator (icd) * patients on a holter monitor
illness management and recovery treatment integrity scale validation and leadership intervention development

Conditions: Severe Mental Illness

Summary: illness management and recovery (imr) is an evidenced-based approach to teaching consumers with severe mental illness how to set and achieve personal recovery goals and acquire the knowledge and skills to independently manage their illnesses. longitudinal, multi-site, and randomized controlled trials have shown imr to be effective in increasing illness self-management and coping; some evidence also points to reduced hospitalization rates. fidelity, or adherence to a specific treatment model, is equally important to both clinical research and to the practical dissemination of evidence-based practices to the field. to this end, the research team has developed an imr clinician-level fidelity assessment, the imr treatment integrity scale (it-is). however, the validity of the preliminary it-is has not been rigorously evaluated. additionally, it is crucial to develop strategies to utilize the it is to increase adherence to the imr model and ultimately increase consumer outcomes. the purpose of this study is to assess the construct validity of the it-is by testing the relationship between it-is elements and mechanisms of change and proximal outcomes. the investigators will collect a sample of imr session recordings and pre-post data from imr participants from recruitment sites in indiana, new jersey and several other states. the investigators will test hypothesized relationships between specific program elements and theoretically proposed mechanisms of change. the investigators will also assess organizational and clinician factors affecting imr competence by including a survey for the staff members who are located as sites where the investigators have clinicians participating in providing imr.


Eligibility criteria:
inclusion criteria: clinicians: * 18 years or older * providing imr individually or in group format at a participating agency * willing and able to provide consent * willing to complete study measures * willing to be audio recorded consumers: * 18 years or older * willing and able to provide consent * able to complete a brief cognitive screener * willing to complete study measures * receiving imr intervention at a participating agency * willing to be audio recorded exclusion criteria: * individuals younger than 18 years old
facilitated antegrade steering technique in chronic total occlusions (fast-ctos)

Conditions: Coronary Artery Chronic Total Occlusion

Summary: prospective, non-randomized, multicenter study in subjects with coronary artery chronic total occlusions (ctos). published results of safety and effectiveness of conventional techniques will be used for comparison. enrollment of up to 149 subjects with a cto refractory to currently marketed guidewire use and meeting all inclusion/exclusion criteria at up to 15 us clinical sites. hypothesis is that the bridgepoint medical system is safe and effective in treating coronary ctos compared to cto literature.


Eligibility criteria:
inclusion criteria: * suitable candidate for non-emergent, coronary angioplasty * documented coronary cto lesion with the following characteristics: a) thrombolysis in myocardial infarction (timi) 0 flow for at least 90 days; b) satisfactory distal vessel visualization; and c) refractory to currently marketed guidewire crossing via 1 of the following: 1. previous failed attempt to cross cto within the past 12 months; or 2. unsuccessful cto crossing w/ guidewire (10-15 min fluoro time); or 3. attempt to cross cto w/ guidewire results in subintimal guidewire * angina or ischemia caused by the occluded artery * at least 18 years of age * body mass index (bmi) \< 40 * left ventricle ejection fraction \> 20% * sign the informed consent form exclusion criteria: * saphenous vein graft (svg) cto or an in-stent cto * aorto-ostial cto location. (ostial bifurcation origins may be considered) * intolerance to aspirin or a neutropenic response to ticlopidine/clopidogrel * appearance of thrombus or intraluminal filling defects * severe cerebrovascular disease (history of stroke or tia within 1 month) * cardiac intervention within two weeks of the procedure * renal insufficiency (serum creatinine of \> 2.3 mg/dl) * active gastrointestinal bleeding * active infection or fever that may be due to infection * life expectancy \< 2 years due to other illnesses * significant anemia (hemoglobin \< 8.0 mg / dl) * severe uncontrolled systemic hypertension * severe electrolyte imbalance * anaphylaxis to angiographic contrast media unless appropriately medicated * congestive heart failure \[new york heart association (nyha) class iv\] * unstable angina requiring emergent percutaneous transluminal coronary angioplasty (ptca) or coronary artery bypass graft (cabg) * recent myocardial infarction (mi)(within the past two weeks) * uncontrolled diabetes * participation in another investigational protocol * unwillingness or inability to comply with any protocol requirements * pregnant or nursing * extensive dissection from refractory guidewire use * crossing cto (true lumen) w/ guidewire within 10-15 min of fluoro time

Keywords: cto chronic total occlusion cad coronary artery disease interventional cardiology revascularization recanalization
financial incentives telephone education and skills trial in african americans with diabetes (fitest)

Conditions: Diabetes Mellitus; Type 2 Diabetes Mellitus; Adult-Onset Diabetes Mellitus; Non-Insulin-Dependent Diabetes Mellitus; Noninsulin Dependent Diabetes Mellitus, Type II

Summary: the aim of this study is to test the efficacy of financial incentives augmented telephone-delivered diabetes education and skills training intervention in improving hba1c levels in african americans (aa) with type 2 diabetes (t2dm).

african americans with t2dm have higher prevalence of diabetes, poorer metabolic control, and greater risk for complications and death compared to white americans. hba1c is the primary marker for glycemic control and is a strong independent predictor of development of complications and increased mortality in t2dm. key self-care behaviors that influence glycemic control (and hba1c) include diet, physical activity, self-monitoring of blood glucose and medication adherence. systematic review of multiple rcts show that self-care interventions that include diabetes education and skills training are effective in improving metabolic control in diabetes. recent findings indicate that patients with diabetes, especially ethnic minority patients, prefer telephone-delivered diabetes education to group visits or internet-based education. multiple rcts have documented the effectiveness of telephone-delivered self-care interventions in t2dm. the overarching aim of this proposal is test the efficacy of three financial incentive structures in combination with technology intensified diabetes education and skills training intervention on blood pressure and quality of life in aas with t2dm. 60 aas with t2dm will be randomized to three groups with varying frequency of financial incentives: 1) high frequency: financial incentives for weekly uploads plus average glucose, incentives for weekly attendance to educational sessions, and incentives at the end of the study for meeting hba1c goals 2) moderate frequency: financial incentives for weekly uploads plus average glucose, and incentives at the end of the study for meeting hba1c goals, and 3) low frequency: financial incentives at the end of the study for meeting hba1c goals.

Eligibility criteria:
inclusion criteria: * age ≥21 years * clinical diagnosis of t2dm and hba1c ≥8% at the screening visit * self-identified as aa * subject must be willing to use the fora monitoring system for 3 months * subjects must be able to communicate in english * subjects must have access to a telephone (landline for data uploads) for the study period exclusion criteria: * mental confusion on interview suggesting significant dementia * participation in other diabetes clinical trials * alcohol or drug abuse/dependency * active psychosis or acute mental disorder * life expectancy \<12 months

Keywords: diabetes mellitus, type 2 diabetes mellitus, adult-onset diabetes mellitus, non-insulin-dependent diabetes mellitus, noninsulin dependent diabetes mellitus, type ii african american blacks non-hispanic blacks randomized control trial controlled clinical trial behavioral research behavioral medicine
safety study of a melanoma vaccine (gvax) with or without cyclophosphamide in patients with surgically resected melanoma

Conditions: Melanoma

Summary: the primary objective of this study is to evaluate the safety and feasibility of administering an allogeneic gm-csf-secreting lethally irradiated whole melanoma cell vaccine ("melanoma gvax"), alone or in combination with low dose cyclophosphamide (cpm), for the adjuvant treatment of patients with surgically resected stage iib-iv melanoma. secondarily, the investigators will assess in vitro correlates of anti-melanoma immunization by melanoma gvax, including serological and cellular immune responses in patients treated with either the vaccine alone or the vaccine given with low dose cpm.


Eligibility criteria:
inclusion criteria: * any patient age ≥18 years with melanoma of cutaneous or mucosal origin, and with clinicopathologic stage iib, iic, iii or iv that has been completely resected * patients must be able to provide informed consent. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * life expectancy of at least 6 months. * adequate hematologic function. * adequate renal function * adequate hepatic function * patients of both genders must agree to practice effective birth control during the study period and for at least 4 weeks after the last treatment. exclusion criteria: * patients whose primary site of melanoma is ocular. * are undergoing or have undergone in the past 4 weeks any systemic treatment for melanoma. * are undergoing or have undergone in the past 2 weeks any surgery or focal radiation therapy. * have active systemic infections, coagulation disorders (including therapeutic anticoagulation), or other major medical or psychiatric illnesses. * are known to be positive for hepatitis b surface antigen, anti-hepatitis c virus or anti-human immunodeficiency virus (hiv) antibody (because of possible immune effects of these conditions). * documented history of autoimmune disease, for example, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis. * any form of primary or secondary immunodeficiency. this would include hereditary disorders such as ataxia-telangiectasia or wiskott-aldrich syndrome, or acquired immune deficiencies such as following bone marrow transplantation. * requirement for systemic steroid therapy or immunosuppressive therapy. * have received any type of cancer immunotherapy, including but not limited to interleukin-2, interferon alfa or melanoma vaccines. * have been diagnosed with another invasive cancer within the past 3 years. * radiographic evidence of melanoma recurrence. * pregnant or lactating women. * known or suspected hypersensitivity to gm-csf, pentastarch, hetastarch, corn, dimethyl sulfoxide, fetal bovine serum or trypsin (porcine origin).

Keywords: immunotherapy vaccine gvax gm-csf
surveillance study of acute gastroenteritis in hospitalized children in rural area in lebanon

Conditions: Acute Gastroenteritis; Diarrhea; Rotavirus

Summary: acute gastroenteritis is a common cause of hospitalization in children with significant socioeconomic burden on the health community, we will follow in this observational and analytical study the admitted cases of acute gastroenteritis to the pediatric floor at the sheikh ragheb harb hospital over a period of summer time to determine the causes, etiologies and epidemiology of age in a community hospital.

in this survey of hospitalized cases of acute gastroenteritis, children between two months and up to ten years old are included except for known cases of chronic diarrhea, malnutrition or immunodeficiency, data collected include clinical signs and symptoms, epidemiologic information and laboratory data during the hospital stay, also hospital treatment will be reviewed to determine the therapeutic options available in our country and its convenience with the disease and clinical conditions.

Eligibility criteria:
inclusion criteria: * children with acute gastroenteritis admitted to the pediatric floor exclusion criteria: * chronic diarrhea or immunodeficiency

Keywords: gastroenteritis hospitalized children
evaluation of the suitability of pd p 506 a in the pdt of distal subungual onychomycosis (dso) of the great toenail.

Conditions: Onychomycosis

Summary: this study evaluates the potential usefulness of photodynamic therapy with pd p 506 a in patients with distal subungual onychomycosis of the great toenail. patients will receive four pdt treatments with pd p 506 a in weekly intervals.


Eligibility criteria:
inclusion criteria: * male 18 - 75 years of age * females up to an age of 75 years provided that they are postmenopausal, i.e. with spontaneous amenorrhea for at least 12 months or not of childbearing potential because of tubal ligation or hysterectomy * dso of at least one of the great toe(s) affecting 20% to 60% of the target nail without spikes, confirmed before visit 1 by at least one of the three methods: the methods of koh test, periodic acid-schiff (pas) stain and mycology culture * the toenail infection can be due to a dermatophyte, yeast or mixed infections (dermatophyte and non-dermatophyte) * toenails have to be cut regularly (indicator for existing growth) * signed written informed consent exclusion criteria: * patients with the target toenail involving the matrix (lunula) or having less than 2 mm clear (unaffected) nail plate length beyond the proximal fold * presence of dermatophytoma (defined as demarcated and localised thick masses (≥ 3 mm) of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail * other conditions than dso known to cause abnormal nail appearance * topical antifungal treatment of the nails within 1 month before pdt * systemic use of antifungal treatment within 3 months before pdt * patients who are unwilling to provide nail clippings * patients who have been previously reported to be allergic against 5-aminolevulinic acid or other ingredients of pd p 506 a * diagnosis of porphyria * diagnosis of polyneuropathy * dementia or psychic condition that might interfere with the ability to understand the study and thus give written informed consent * simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment
specified drug use results survey of ipragliflozin treatment in type2 diabetes patients

Conditions: Type 2 Diabetes

Summary: the objective of this survey is to confirm the safety of suglat tablets

the objective of this survey is to confirm the safety and efficacy of suglat tablets for long-term use over 3 years. specify the effects of suglat tablets on the cardiovascular system, incidence rates of malignant tumor, and their risk factors. investigate the occurrence of adverse drug reactions. specify factors that may possibly influence the safety and efficacy of suglat tablets. \ * hypoglycemia * genital infection * urinary tract infection * polyuria and pollakiuria * adverse events related to a decrease in body fluids (dehydration, etc.) * malignant tumor * cardiovascular diseases

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes who first use suglat tablets during the period from july 17, 2014 to july 16, 2015 exclusion criteria: * off-label use patients

Keywords: suglat sglt-2 inhibitor ipragliflozin l-proline asp1941 long-term use
antimicrobial stewardship program and ventilator associated pneumonia

Conditions: Ventilator Associated Pneumonia

Summary: antibiotic stewardship programs (asps) help clinicians improve the quality of patient care and improve patient safety through increased infection cure rates, reduced treatment failures; however, there are different techniques, with variable results, of its application including what is called asps bundle and there is a need to investigate the effectiveness of implementing a comprehensive care bundle program including the key components of asps and the key items of infection control measures, this program can be called antimicrobial stewardship comprehensive care bundle program (asccbp).

survey experimental study will be done in the first 6 months as regard antimicrobial drugs pattern and organism's sensitivity and resistance pattern in vap patients. in the next six months, clinical implementation of asps and infection control bundle will be applied on vap patients. then, in the later six months the investigators will study the outcome of vap patients as regard: * amount of cost of antibiotics. * appropriates of antibiotic use (initiation, duration \& time of discontinuation). * rate of resistance * clinical outcome, infection rate \&length of stay. regular reports on antibiotic use and resistance will be admitted to relevant staff every one month. also, audit and feedback about resistance and optimal prescribing will be applied every one month for icu stuff as an open discussion. the stewardship consulting team will include microbiologist with clinical experience in the field of antibiotic use and infection control. stewardship team also will include the relevant icu staff and an experienced clinical pharmacist.

Eligibility criteria:
inclusion criteria: • patients, ≥18 years, who were intubated and mechanically ventilated for more than 48 hours in icu and showing clinical criteria of vap exclusion criteria: * patients on immunosuppressive drugs. * patient with chronic lung disease, chronic liver disease\& chronic renal disease. * immunocompromised patients. * patients intubated and mechanical ventilated outside the icu before admission. * patients manifested clinically with picture suggestive of vap but less than 48 hours on mechanical ventilation.